Parasitic Ulcer Treatment Trial
Research type
Research Study
Full title
Parasitic Ulcer Treatment Trial
IRAS ID
1009847
Contact name
Su-yin Koay
Contact email
Sponsor organisation
University of California, San Francisco
Clinicaltrials.gov Identifier
Research summary
This study is a randomized trial assessing the efficacy and safety of topical corticosteroids when used as adjunctive therapy in acanthamoeba corneal infections. Acanthamoeba keratitis (AK) is an uncommon eye infection that is painful, difficult to treat, and often results in vision impairment. The role of topical corticosteroids is not clear. On one hand, topical steroids may reduce the scarring that causes vision loss in AK. But on the other hand, topical steroids have been shown to promote growth of acanthamoeba in laboratory studies. In the proposed trial, participants diagnosed with AK will be treated with standard of care anti-amoebic therapy (polyhexamethlyene biguanide [PHMB] eyedrops) for 4 weeks. Eyes with ocular inflammation after 4 weeks of anti-amoebics will be randomized in a 1:1 ratio to a 2-month course of either topical corticosteroids (dexamethasone 0.1%) or topical placebo (artificial tears). The rationale for starting steroids at 4 weeks is that this timing should be late enough to allow sufficient time for anti-amoebics to work but early enough to still gain anti-inflammatory benefits. Participants and investigators will not know if they are receiving steroids or placebo. The primary outcome will be 6-month visual acuity, and the main secondary outcomes will be pain at 2 months and time to clinical cure. It is possible that certain host or pathogen factors may modify the effectiveness of steroids. Thus, corneal swabs will be collected at the time of AK diagnosis and metagenomic deep sequencing will be performed to evaluate pathogen virulence factors and host gene expression. The trial will be overseen by a Data and Safety Monitoring Committee (DSMC).
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0054
Date of REC Opinion
25 Jul 2025
REC opinion
Further Information Favourable Opinion